Table 5.

Adverse Event Rates by Treatment Arm and Estimated Over- or Under-Reporting for Trial Z9001

Adverse Event	% Imatinib Patients (A)	% Placebo Patients (B)	% Patients With Event Due to Imatinib Based on Data (C = A − B)	% Patients With Event Due to Imatinib Based on Treating Physician (D)	% Physician Over- or Under-Reporting Attribution [E = (D − C)/C]
Edema, head/neck	45	14	30	43	42
Nausea	50	27	22	45	100
Leukopenia	18	6	12	17	44
Anemia	45	29	17	36	117
Neutropenia	17	6	10	15	46
Rash/desquamation	33	19	13	29	119
Edema	10	3	7	8	17
Edema, limb	24	13	11	1	−87
Vomiting	24	14	10	17	66
Fatigue	53	40	13	47	252
Tearing	10	4	6	9	47
Pain, extremity	12	6	7	6	−3
Anorexia	16	9	7	13	80
Creatinine	12	6	5	7	32
Weight loss	10	5	5	5	7
Hypokalemia	9	4	5	3	−29
Constipation	12	18	—	6	—